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Marker Therapeutics Announces Completion of Safety Lead-In Portion of Phase 2 Study in Post-Transplant AML
Company continues to enroll patients in main portion of the Phase 2 trial with topline data from active disease group expected in Q1 2022 HOUSTON, July 6,
About this update from Marker Therapeutics, Inc.
[{"type":"text","content":"Company continues to enroll patients in main portion of the Phase 2 trial with topline data from active disease group expected in Q1 2022\n\n\nHOUSTON, July 6, 2021 /PRNewswire/ -- Marker Therapeutics, Inc. (Nasdaq:MRKR), a clinical-stage immuno-oncology company specializing in the development of next-generation T cell-based immunotherapies for the treatment of hematological malignancies and solid tumor indications, today announced completion of the six-patient safety lead-in portion of the Company's Phase 2 trial of MT-401, its lead MultiTAA-specific T cell product candidate, for the treatment of post-transplant acute myeloid leukemia (AML). \n\n \n \n \n \n \n \n\n \n\"We are pleased with the results of the safety lead-in portion of the trial, in which all six patients met the safety endpoints following infusion of our MultiTAA-specific T cell therapy,\" said Mythili Koneru, M.D., Ph.D., Chief Medical Officer of Marker Therapeutics. \"We are currently enrolling patients in the main portion of our first Company-sponsored trial and continue to activate clinical sites across the U.S. We are looking forward to further advancing MT-401 in this disease setting. Despite recent advances in how hematological malignancies are treated, patients remain in urgent need of new therapeutic options.\"\nAbout Marker's Phase 2 AML Post-Transplant Study\nThe multicenter Phase 2 AML study is evaluating the clinical efficacy of MT-401 in patients with AML following an allogeneic stem-cell transplant in both the adjuvant and active disease setting. In the adjuvant setting, approximately 120 patients will be randomized 1:1 to either MT-401 at 90 days post-transplant versus standard-of-care observation, while approximately 40 patients with active disease will receive MT-401 as part of the single-arm group. \nThe primary objectives of the trial are to evaluate relapse-free survival in the adjuvant group and determine the complete remission rate and duration of complete remission in active disease patients. Additional objectives include, for the adjuvant group, overall survival and graft-versus-host disease relapse-free survival while additional objectives for the active disease group include overall response rate, duration of response, progression-free survival and overall survival. \nIn April 2020, the FDA granted Orphan Drug designation to MT-401 for...